Marketing Issues

The expanded-use protocol is a good selling tool. It allows the physician to become familiar with the drug before its actual marketing. However, it also creates the opportunity for overly enthusiastic drug representatives to try to sell the physician on the drug before FDA approval to market the drug and approval of the final package insert text. This may appear to be advertisement for the drug before its approval, which is prohibited by FDA regulations and, as such, would be subject to legal action by the FDA. It may also create a false sense of hope and security among patients and physicians and flood the sponsor with expanded-use requests for a compound that is in limited supply.

During the expanded-use protocol, the drug is generally provided free to patients even though the regulations do provide for the possibility of payment. Offering the drug at no charge fosters a positive and benevolent image of the company. Conversely, charging patients for a drug before marketing it can create an equally negative public opinion of the company. Preexisting marketed drugs may also face competition from unapproved agents sold under a large expanded-use IND program, despite the lack of evidence to support safety and efficacy. Charging for the drug under an expanded-use program requires prior approval, by the FDA. The charge for the drug may not exceed the cost of developing the drug, which may further put the sponsor at risk for negative publicity after approval when patients learn the difference between preapproval costs and retail costs.

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